Clinical Trial: Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic

Brief Summary: The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous ibuprofen will provide a clinically significant drop in self-reported patient pain level as measured by the visual analog scale.

Detailed Summary:

It is estimated over 20 million people aged 20-74 have gallbladder disease, with biliary colic being a common and painful symptom in these patients. Likely due to the relatively recent approval of intravenous ibuprofen use for fever and pain in adults, no assessment of its analgesic efficacy for biliary colic currently exists in the literature.

Utilizing a visual analog scale (VAS) for patient self-assessment of pain, this study will address this lack of evidence and identify intravenous ibuprofen's value as a novel analgesic in the treatment of biliary colic. Patients will be given a VAS at the time of study therapy administration, at 15-minute intervals during the first hour post-administration, and 30-minute intervals in the second hour. Though NSAID's have been extensively studied in the management of this phenomenon, this study aims to help optimize pain treatment of patients presenting to the Emergency Department with biliary colic, and potentially pave the way for future analgesic treatment comparison studies.


Sponsor: Maricopa Integrated Health System

Current Primary Outcome: Pain Level - VAS [ Time Frame: 15 minutes post-administration ]

Pain levels measured through Visual Analog Scale (VAS)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from pain level (VAS) at 15 minutes post-administration [ Time Frame: 30 minutes post-administration ]
    Pain levels measured through Visual Analog Scale (VAS)
  • Change from pain level (VAS) at 30 minutes post-administration [ Time Frame: 45 minutes post-administration ]
  • Change from pain level (VAS) at 45 minutes post-administration [ Time Frame: 60 minutes post-administration ]
  • Change from pain level (VAS) at 60 minutes post-administration [ Time Frame: 90 minutes post-administration ]
  • Change from pain level (VAS) at 90 minutes post-administration [ Time Frame: 120 minutes post-administration ]


Original Secondary Outcome: Same as current

Information By: Maricopa Integrated Health System

Dates:
Date Received: October 16, 2014
Date Started: September 2014
Date Completion: September 2016
Last Updated: November 4, 2015
Last Verified: November 2015